← Product Code [JOP](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/JOP) · K912409

# MODEL HD-207 BIDIRECTIONAL VELOCITY METER (K912409)

_Koven and Assoc., Inc. · JOP · Dec 23, 1991 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-c%E2%80%94cardiovascular-monitoring-devices/JOP/K912409

## Device Facts

- **Applicant:** Koven and Assoc., Inc.
- **Product Code:** [JOP](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/JOP.md)
- **Decision Date:** Dec 23, 1991
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.2880
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

An ultrasonic transducer is a device applied to the skin to transmit and receive ultrasonic energy that is used in conjunction with an echocardiograph to provide imaging of cardiovascular structures. This device includes phased arrays and two-dimensional scanning transducers.

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-c%E2%80%94cardiovascular-monitoring-devices/JOP/K912409](https://fda.innolitics.com/submissions/RA/subpart-c%E2%80%94cardiovascular-monitoring-devices/JOP/K912409)

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